Widening access to care and supportfor people living with HIV/AIDS
PROGRESS REPORT, JUNE 2002
AcceleratingAccess Initiative
ISBN 92 4 121012 5
WORLD HEALTH ORGANIZATION
For orders, contact:World Health OrganizationFamily and Community Health ClusterDepartment of HIV/AIDS20, avenue AppiaCH-1211 Geneva 27Switzerland
E-mail: [email protected]
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Widening access to care and supportfor people living with HIV/AIDS
PROGRESS REPORT, JUNE 2002
AcceleratingAccess Initiative
WORLD HEALTH ORGANIZATION
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WHO Library Cataloguing-in-Publication Data
Accelerating Access Initiative: widening access to care and support for people living with HIV/AIDS:progress report, June 2002.
1.Anti-HIV agents - supply and distribution 2.Drug industry 3.Drug costs 4.International co-operation5.Intersectoral co-operation 6.Developing countries
ISBN 92 4 121012 5 (NLM/LC classification: QV 268.5)
© World Health Organization 2002
© World Health Organization and UNAIDS 2002
All rights reserved. Publications of the World Health Organization can be obtained from Marketing and Dissemination, World Health Organization, 20 AvenueAppia, 1211 Geneva 27, Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; email: [email protected]). Requests for permission to reproduce ortranslate WHO publications - whether for sale or for noncommercial distribution - should be addressed to Publications, at the above address(fax: +41 22 791 4806; email: [email protected]).
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The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World HealthOrganization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products aredistinguished by initial capital letters.
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ACCELERATING ACCESS III
ContentsAcknowledgements ivAcronyms and Abbreviations vExecutive Summary 1Introduction 3Aims of Accelerating Access 4How the Initiative Works 5Achievements 7Limitations 10Related Activities 13Lessons Learned 15Conclusion 16Further Reading 17Annexes 19
Annex 1: Accelerating access to HIV/AIDS care and treatment in developing countries 19Annex 2: Countries that have expressed interest in Accelerating Access 21Annex 3: Estimated numbers of African patients on antiretroviral therapy 23Annex 4: Prices of ARVs in the Accelerating Access Initiative 28Annex 5: Offers for antiretroviral drugs by proprietary companies for developing countries 29
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Acknowledgements
This report was compiled by B. Samb (WHO), J. Perriëns (WHO), H. Tracey (UNAIDS)and J. Fleet (UNAIDS). WHO and UNAIDS would like to acknowledge the help ofG. Dwyer (editing and graphic design) and Segundo dela Cruz, Jr. (typesetting). Annex3 was contributed to this report by the participating companies (Abbott Laboratories;Boehringer Ingelheim GmbH; Bristol-Myers Squibb; GlaxoSmithKline; F. Hoffmann-La Roche Ltd.; and Merck & Co., Inc.).
IV ACCELERATING ACCESS
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ACCELERATING ACCESS V
Acronyms andAbbreviationsAcronyms
AIDS acquired immunodeficiency syndromeARV antiretroviralCARICOM Caribbean CommunityECOWAS Economic Community of Western African StatesHAART highly active antiretroviral therapyHIV human immunodeficiency virusMAP Multi-Country HIV/AIDS Programme for AfricaMTCT mother-to-child transmission (of HIV)NGO nongovernmental organizationTB tuberculosisUN United NationsUNAIDS United Nations Joint Cosponsored Programme on HIV/AIDSUNFPA United Nations Population FundUNGASS United Nations General Assembly Special Session on HIV/AIDSUNICEF United Nations Children’s FundWHO World Health Organization
Drug abbreviations
ABC abacavirAPV amprenavird4T stavudineddC zalcitabineddI delavirdineEFZ efavirenz (also abbreviated as EFV)IDV indinavirLPV lopinavirNFV nevirapineNNRTI Non-Nucleoside Reverse Transcriptase InhibitorNRTI Nucleoside Reverse Transcriptase InhibitorPI protease inhibitorRTV, r ritonavirRTV-PI ritonavir boosted protease inhibitorSQV saquinavirTDF tenofovir disoproxil fumarateZDV zidovudine (also known as AZT)
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ACCELERATING ACCESS 1
Executive SummaryThe World Health Organization (WHO)and Joint United Nations Programme onHIV/AIDS (UNAIDS) estimate that in 2001about 3 million people died from AIDS, withthe vast majority of these deaths occurringin developing countries. While theavailability of antiretroviral (ARV) therapyhas significantly reduced AIDS morbidityand mortality in the industrialized world,in developing countries, where 95% of HIV-positive people live, the overwhelmingmajority of HIV-positive people do not haveaccess to these life-sustaining medications.
WHO conservatively estimates that in2002, around 6 million people in developingcountries are in need of ARV therapy. Yetonly about 230,000 people living with HIVin those countries have such access today.Half of these live in one country, Brazil.
Access to medicines is dependent on theirrational selection and use, the availabilityof financial resources, the strength of thehealth infrastructure and their affordability.As the high cost of medicines is a majorfactor limiting access to ARVs in developingcountries, in May 2000 five UNorganizations (the United NationsPopulation Fund [UNFPA], United NationsChildren’s Fund [UNICEF], World HealthOrganization [WHO], World Bank andUNAIDS Secretariat) entered into apartnership offered by five pharmaceuticalcompanies (Boehringer Ingelheim GmbH;Bristol-Myers Squibb; GlaxoSmithKline;Merck & Co., Inc.; and F. Hoffmann-LaRoche Ltd. – later joined by AbbottLaboratories) to address the lack ofaffordability of HIV medicines and to worktogether to increase access to HIV/AIDS careand treatment in developing countries.
Since the launch of Accelerating Accessin May 2000, 80 countries have expressedtheir interest in the Initiative. In 39 of thesecountries, national plans to improve accessto care have been or are being developed.These plans have been used as a frameworkfor dialogue with the pharmaceuticalcompanies, and as a consequence, 19countries (Barbados, Benin, Burkina Faso,Burundi, Cameroon, Chile, Republic of theCongo, Côte d’Ivoire, Gabon, Honduras,Jamaica, Mali, Morocco, Romania,Rwanda, Senegal, Trinidad and Tobago,Uganda, and Ukraine) have concludedagreements for the supply of their ARVdrugs with individual companiesparticipating in the Initiative. In each ofthese countries the pharmaceuticalcompanies involved, acting independently,have significantly reduced the cost of theirdrugs. In addition, several companies havealso made their drugs available at reducedcost to governments, nongovernmentalorganizations (NGOs), private sectoremployers and health care organizationsoutside the framework of the AcceleratingAccess Initiative. In May 2002, two majorgroups of countries coalesced to engage innegotiation with the individualpharmaceutical companies, with WHO andUNAIDS support, through the AcceleratingAccess Initiative. These are the EconomicCommunity of Western African States(ECOWAS) and the Caribbean Community(CARICOM). Formal statements of intentbetween ECOWAS and CARICOM,respectively, and the companies, areexpected to be signed in July 2002.
The 19 countries that have concludedsupply agreements within the Accelerating
Since the
launch of
Accelerating
Access in May
2000, 80
countries have
expressed their
interest in the
Initiative.
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2 ACCELERATING ACCESS
Despite the
major
reductions in
ARV prices, the
annual cost of
ARV treatment
for a person
living with HIV
still exceeds
the annual per
capita gross
domestic
product of
many least
developed
countries.
gross domestic product of many leastdeveloped countries. Thus, procurement ofARVs solely through domestic financingremains almost impossible in manycountries. While far greater investments inhealth and social services infrastructureare needed to expand access to treatmenton a massive scale, many countries haveunderutilized health system capacity that,but for lack of financing and affordability,could be used to expand treatment today.
In spite of the limited number of patientstreated to date, however, the Initiative hascontributed significantly to overcoming theinertia surrounding treatment access indeveloping countries. A marked shift hasoccurred in perceptions of how the HIVepidemic can be tackled. The Declarationof Commitment by the United NationsGeneral Assembly Special Session(UNGASS) on HIV/AIDS reflects this shift,recognizing that care for people living withHIV/AIDS is an integral part of the fightagainst AIDS, and making specific mentionof ARV therapy as an important elementof comprehensive care.
This increased recognition of care as animportant element of the fight againstAIDS is reflected in several recentimportant developments. Supporting accessto treatment is a central part of the agendaof the recently established Global Fund toFight AIDS, TB and Malaria (the GlobalFund). HIV/AIDS accounted for more than60% of the funding committed followingthe first round of proposal submissions inApril 2002. Total funding committed overtwo years in this round of proposals, forAIDS, TB and malaria prevention andtreatment programmes, amounts toUS$616 million. Of the 28 countries thatwill receive funds to fight HIV/AIDS, 21have grants that specifically includefunding to purchase ARV treatments forpeople living with HIV/AIDS. In addition,the World Bank’s Multi-Country HIV/AIDS Programme for Africa (MAP),initiated in 2001, recently decided to re-emphasize support for HIV/AIDS care andtreatment as part of its eligible activities.
Access Initiative have all moved to waiveimport taxes and duties on drugs used inHIV/AIDS treatment, and some countriesintroduced generic ARV drugs in thetreatment of HIV infection at competitiveprices – in one instance for as low asUS$295 for a year’s treatment with a firstline triple ARV therapy regimen.
As of December 2001, the cost of ARVdrugs offered individually by thepharmaceutical partners in theAccelerating Access Initiative for the leastdeveloped countries had decreasedsignificantly, in some cases to 10–20% oftheir price in industrialized countries.About 27 000 people had gained access toARV therapy in the 19 countries in Africa,Eastern Europe, and Latin America and theCaribbean that had concluded supplyagreements within the Accelerating AccessInitiative framework. This represents anearly 10-fold increase in the number ofpatients treated in those countries.
In addition, the public offer of lowerprices led to an increased uptake of ARVsin Africa outside the Accelerating AccessInitiative framework. In Africa, the sixcompanies involved in the Initiative hadsupplied treatment to more than 35 500people as at the end of March 2002, partwithin and part outside the AcceleratingAccess Initiative countries. Their data alsoshow that in Africa the proportion ofpatients on triple combination therapy upto that time increased from one third tonearly two thirds, which indicates aconcomitant increase in the quality of ARVtreatment.
While this is significant progress, thesenumbers represent only a fraction of thosein need of ARVs. The failure to reach morepeople with ARV therapy in resourcelimited settings reflects the persistinglimited availability of funding formedicines, diagnostics and infrastructure,as well as continued lack of affordabilityin many countries. Despite the majorreductions in ARV prices, the annual costof ARV treatment for a person living withHIV still exceeds the annual per capita
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ACCELERATING ACCESS 3
IntroductionThe World Health Organization (WHO)and the Joint United Nations Programmeon HIV/AIDS (UNAIDS) estimated that atthe end of 2001, more than 40 millionpeople were living with HIV/AIDSworldwide. More than 28.1 million werein sub-Saharan Africa, a region thataccounts for about 2.3 million of theestimated 3 million adult and child deathsrelated to AIDS in 2001. In addition, morethan 20 million lives have been lost to AIDSsince the start of the epidemic in the early1980s.
This death toll could have been lower ifhighly active antiretroviral therapy(HAART), which was introduced for thetreatment of HIV in 1996, had beenavailable more widely. EverywhereHAART was introduced, spectacularimprovements in the treatment of HIVpatients ensued, dramatically reducingmortality among treated patients by about70% and improving their quality of life.Where HAART was introduced, itchanged the perception of HIV/AIDS froma death sentence to that of a manageablechronic illness.
However, in many developing countries,people living with HIV/AIDS do not haveaccess even to basic treatment foropportunistic infections, or to palliativecare. The injustice of this treatment gapled to a wide movement for treatmentaccess, led by people living with HIV andby civil society.
In 1998, the UNAIDS Secretariat, withseveral pharmaceutical partners,introduced the Drug Access Initiativewhich explored the feasibility of a
structured introduction of price-reducedARV therapy in a range of developingcountries. The Drug Access Initiative whichestablished that antiretroviral (ARV)therapy could be safely and effectivelyused, even in the least developed countries,led to the first differential pricing for ARVsin developing countries, and demonstratedthat diversion of price-reduced drugs couldbe limited. A first evaluation of its activitiespublished in March 2000 found, however,that in the pilot projects the price of thedrugs was the main obstacle to expandingdrug access up to the maximum capacityof the pilot centres. This led the UNAIDSSecretariat and the managers of the DrugAccess Initiative in Uganda and Côted’Ivoire to explore whether the drugs couldbe obtained more cheaply, first from theresearch-based companies that werepartners in the initiative, and later fromgeneric manufacturers. Further action wasalso prompted by public information aboutprices of locally produced ARVs in Braziland Thailand.
Building on this experience, five UNorganizations (the United NationsPopulation Fund [UNFPA], United NationsChildren’s Fund [UNICEF], World HealthOrganization [WHO], World Bank andUNAIDS Secretariat) entered in apartnership offered by five pharmaceuticalcompanies (Boehringer Ingelheim GmbH;Bristol-Myers Squibb; GlaxoSmithKline;Merck & Co., Inc.; and F. Hoffmann-LaRoche Ltd.) in May 2000, joined later byAbbott Laboratories Inc. The presentpaper reports on the progress achievedthrough this partnership.
Where HAART
was introduced,
it changed the
perception of
HIV/AIDS from
a death
sentence to
that of a
manageable
chronic illness.
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4 ACCELERATING ACCESS
Aims of AcceleratingAccessThe Accelerating Access Initiative was setup to explore practical and specific waysof working together more closely toaccelerate access to HIV/AIDS-relatedcare and treatment in developing countries.
The objective of the Accelerating AccessInitiative is to make HIV/AIDS drugs moreaffordable and accessible in developingcountries and to improve technicalcollaboration in the development ofnational programme capacities to delivercare, treatment and support.
The partners in the Initiative agreed toa Joint Statement of Intent (see Annex 1),which sets out the expected benefits of theInitiative, as follows:
■ for people in developing countries, toaccelerate their sustained access to,and increase their use of, appropriate,good quality interventions for theprevention, treatment and care ofHIV/AIDS-related illnesses, and theprevention of perinatal transmissionof HIV;
■ to ensure that care and treatment reachsignificantly greater numbers of peoplein need, through new alliancesinvolving committed governments,private industry, the UN system,development assistance agencies, non-governmental organizations (NGOs)and people living with HIV/AIDS; and
■ to implement public-private co-operation in ways that respond to thespecific needs and requests of
The objective
of the
Accelerating
Access
Initiative is to
make HIV/AIDS
drugs more
affordable and
accessible in
developing
countries...
individual countries, with respect forhuman rights, equity, transparencyand accountability.
The following fundamental principlesunderlie the Initiative:
(i) unequivocal and ongoing politicalcommitment by national governmentsis essential for success;
(ii) strengthened national capacity iscrucial for delivering care andtreatment on an equitable basis;
(iii) engagement of all sectors of nationalsociety and the global community isessential in facilitating access totreatment;
(iv) efficient, reliable and securedistribution systems are necessary toensure that medical supplies and otherconsumables are made available topeople who need them;
(v) significant additional funding fromnew national and internationalsources is necessary for long-termsuccess; and
(vi) continued investment in research anddevelopment by the pharmaceuticalindustry on innovative newtreatments for HIV/AIDS is critical toexpanding the global response toHIV/AIDS. Therefore, intellectualproperty rights should be protected,in compliance with internationalagreements, since society depends onthem to stimulate innovation.
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ACCELERATING ACCESS 5
At global level, the Accelerating AccessInitiative was structured in three workinggroups: (i) country support (in which, inaddition to the pharmaceutical companies,the UNAIDS Secretariat, UNICEF andWHO participated); (ii) communications (inwhich all partners participated); and (iii)procurement (in which the UNAIDSSecretariat, UNFPA, UNICEF and WHOparticipated).
Following the announcement of theAccelerating Access Initiative, govern-ments were informed about the Initiativethrough the UN Theme groups on HIV/AIDS, which is the co-ordinating mechanismin countries for UN action on AIDS at thenational level. Governments were offeredUN input in their planning of care andsupport for people living with HIV/AIDSand requested to signify their possible interestin the Accelerating Access Initiative to theExecutive Director of UNAIDS, who thenensured that the country was approachedby UN staff participating in the countrysupport working group. The latter exploredthe intent of the government, and thenorganized support to the government for thedevelopment of a plan for access to ARVdrugs while promoting comprehensive careand informing the government about allprocurement options, including informationon the availability and cost of generic ARVs.After finalization, with approval of thegovernment, the plan for access to ARVdrugs was transmitted by the UN to thosepharmaceutical companies with which the
government wished to open discussions onprices and transactions. The discussionsinvolved representatives of the governmentand individual pharmaceutical companies,and were facilitated by the UN staff in thecountry support working group. As regionaland sub-regional collaborations developed,at the initiative of governments, the sameprocedure was used to ensure they weretechnically supported.
At global level, there was regularconsultation with the stakeholders in theAccelerating Access Initiative, includinggovernments and NGOs, through theestablishment of the Contact Group onAccelerating Access to HIV/AIDS-relatedCare. The Contact Group provided a forumfor consultation and exchange of views onthe Initiative, as well for a regular updateon progress (Box 1).
How the InitiativeWorks
Box 1 Contact Group — Accelerating Access to HIV/AIDS related care
The Contact Group provides a forum for representatives of governments, people living with and affectedby HIV/AIDS, NGOs and other parties, including the pharmaceutical industry. Through this, they canexchange information and views, engage in consultation and articulate needs and expectations, especiallythose emanating from governments, and provide advice and guidance to the UNAIDS Secretariat, WHO,UNICEF, UNFPA and the World Bank on principles, policy and practice that will apply to the AcceleratingAccess Initiative.
The discussions in the Contact Group are intended to ensure a well-informed co-ordinated, participatoryand transparent approach to the Initiative.
The Contact Group is convened by the UNAIDS Secretariat and Co-sponsors and established by theChair of the UNAIDS Programme Coordinating Board (PCB), in consultation with the UNAIDS Secretariatand members of the PCB.
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6 ACCELERATING ACCESS
The procurement working group definedvarious options for procurement1 for
pharmaceuticals that the Initiative mightpursue. Unfortunately, the partners wereunable to agree initially on an option otherthan individual country-by-countrynegotiation, which proved a labour-intensive and time-consuming process.
1 Such options included procurement by individual countriesor organizations within countries, pooled procurement bycountries or organizations, including on a regional basis,and procurement through a central global agent.
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ACCELERATING ACCESS 7
AchievementsIncreasing accessAt present, of the 80 countries that haveexpressed interest in the AcceleratingAccess Initiative, 39 countries havedeveloped plans of action for HIV/AIDScare. These plans have been used as aframework for dialogue with pharma-ceutical companies and have led tosuccessful UN-brokered supply agreementsfor ARVs in 19 out of the 22 countries thatinitiated and finalized such discussions. Thecountries where UN-brokered supplyagreements were concluded and are nowin effect include Barbados, Benin, BurkinaFaso, Burundi, Cameroon, Chile, Republicof the Congo, Côte d’Ivoire, Gabon,Honduras, Jamaica, Mali, Morocco,Romania, Rwanda, Senegal, Trinidad andTobago, Uganda, and Ukraine. Thegovernments of three countries (Ethiopia,Kenya, and Swaziland) opted for a careagenda that does not include ARVs after afirst planning round with the UN, and,while price reductions are available in theirprivate sectors, have so far not initiateddiscussions with the pharmaceuticalcompanies themselves (Annex 2).
In addition, in May 2002, two majorgroups of countries coalesced to engage innegotiation with the individualpharmaceutical companies, with WHOand UNAIDS support, through theAccelerating Access Initiative. These arethe Economic Community of WesternAfrican States (ECOWAS) and theCaribbean Community (CARICOM).Formal statements of intent betweenECOWAS and CARICOM, respectively,and the industry companies are expectedto be signed in July 2002. Fifteen
Caribbean countries and 15 West Africancountries are involved in these regionaldiscussions.
In the first 19 countries in Africa,Eastern Europe, and Latin America and theCaribbean to conclude supply agreements,as of December 2001, about 27 000 peoplehad gained access to ARV therapy,representing an almost 10-fold rise in thenumber of patients treated.
Reduced pricesAchieving lower prices for ARVs has beena significant achievement of theAccelerating Access Initiative, asaffordability is a fundamental starting pointfor increasing access.
When HAART was introduced in 1996,conventional wisdom held that it wouldremain financially and logistically beyondthe reach of most HIV-positive people indeveloping countries for the foreseeablefuture. The Accelerating Access Initiativechanged this perception: within months thecost of ARV drugs offered individually bythe pharmaceutical partners in theAccelerating Access Initiative for the leastdeveloped countries decreased, in somecases to 10–20% of their price inindustrialized countries. Emergingcompetition from generic manufacturersfor some drugs also was a critical factor,in particular on the cost of first lineregimens that do not include proteaseinhibitors, as illustrated by the evolutionof the price of a first line ARV regimen inUganda (Figure 1 overleaf).
However, the Accelerating AccessInitiative for the first time brought abouttransparent differential pricing for ARVs
Achieving lower
prices for ARVs
has been a
significant
achievement of
the
Accelerating
Access
Initiative.
Int. Accelerating Access... 7/01/03, 11:347
8 ACCELERATING ACCESS
Figure 1 Price reductions of a first line ARV regimen in Uganda
WHA Technical Briefing 2002.
in the least developed countries, and led tothe first significant move in transactedprices in its target countries and beyond,on the African continent. Mainly as aconsequence of this transparent pricingpolicy, Africa was able to significantlyincrease the number of people treated, bothwithin and outside the framework of UNbrokered supply agreements within theAccelerating Access Initiative. Accordingto estimates compiled on behalf of the sixcompanies involved in the AcceleratingAccess Initiative, about 35 500 people inAfrica were being treated with ARVssupplied by the six companies by the endof March 2002, a four-fold increase in 18months. In addition, the data show that theproportion of patients on triplecombination therapy over that periodincreased from one third to nearly twothirds, which indicates a concomitantincrease in the quality of ARV treatment.
Annex 3 gives an overview of sales inAfrica by the companies that participatein the Accelerating Access Initiative. Thecost of ARV drugs supplied by theresearch-based companies in agreementsbrokered under the Accelerating AccessInitiative, is given in full in Annex 4. It
should be noted that none of these supplyagreements contain undue restrictions.They are typically concluded for a periodof one year, but leave the buyer the optionto buy from other (i.e., generic) supplysources, consistent with regulatoryrequirements and international agree-ments.
Announcements of price reductionscontinue to be made, the most recent beingAbbott Laboratories’ announcement of19 June 2002 of additional price reductionsfor its anti-HIV drugs lopinavir / ritonavirand ritonavir. The UN will continue to pressfor further decreases where possible, whilerecognizing that the policy of mostcompanies is to cover the costs ofproduction. The UN will also continue topress for increased transparency andaccess to a wider formulary. While pricesin Africa are transparent now, in countriesoutside Africa lack of transparencycontinues to hamper price comparisons,which holds up the ability of those in chargeof treatment programmes to agree on someof the proposed supply agreements. Also,as is evident from the table in Annex 4,supply agreements concluded under theAccelerating Access Initiative between
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ACCELERATING ACCESS 9
countries and the individual pharmaceuticalcompanies outside Africa cover only 11drugs out of the 17 offered by the companiesparticipating in the initiative, as countrydialogues do not yet involve all companies.
Mobilization for careThe demands of treatment activists and civilsociety for equitable access to HIV care havebeen a major factor in drawing worldattention to the gap in treatmentaccessibility. With reduced prices,perceptions about the feasibility ofproviding care to all those who need it havedramatically changed. The inertiasurrounding action on HIV/AIDS carecould be rationalized when prices were farbeyond the reach of people in developingcountries.
But when the price of a first line regimenfell from US$10 000 to around US$350 ayear during the course of two years, peopleliving with HIV/AIDS in developingcountries could see that the medicines anddrugs they needed were almost within theirreach. As is evident from the UNGASScommitments on care, the internationalcommunity has responded to thisconvergence of forces, committing toprovide care including ARV therapy tothose in need.
Without the greatly reduced prices ofARVs in the least developed countriesbrought about through the AcceleratingAccess Initiative, and the significant mediacoverage that ensued, the unwaveringresolve of civil society to address thedisparity between treated and untreatedmight have continued to meet resistancefrom the international developmentcommunity. Instead, the perception thatcare is now possible changed the directionof major international commitments, asreflected, for example, in The Plan of Actionthat came out of the African Development
Forum organized by the EconomicCommission for Africa (ECA) in AddisAbaba, in December 2000; in the AbujaDeclaration on HIV/AIDS, Tuberculosisand other related Infectious Diseases issuedby Organization of African Unity (OAU)Heads of State in April 2001; and in theDeclaration of Commitment on HIV/AIDSadopted at the UN Special Session on HIV/AIDS (UNGASS) in June 2001. Theinclusion of the possibility of purchasingARV drugs within the scope of the GlobalFund to Fight AIDS, TB and Malaria,included in the Framework Agreement ofthe Fund and demonstrated in concreteterms in the first round of grants, and theavailability of World Bank financing forcare and treatment, is further evidence ofthe changed attitude of donors to financingthe purchase of ARVs.
Taxes and dutiesAll 19 countries that entered supplyagreements for ARVs in the AcceleratingAccess Initiative have moved to eliminateor waive import taxes and duties on drugsused in HIV/AIDS treatment.
Other resultsIn addition to offering reduced-pricemedicines, several companies havecontinued or expanded their support for thetraining for health care professionals,strengthening health infrastructure andcapacity.
Boehringer Ingelheim GmbH has offerednevirapine free of charge to developingcountries for the prevention of mother-to-child transmission (MTCT) of HIV, andAbbott Laboratories joined this effort inJune 2002 with an offer of free rapid testsfor MTCT programmes.
With reduced
prices,
perceptions
about the
feasibility of
providing care
to all those
who need it
have
dramatically
changed.
Int. Accelerating Access... 7/01/03, 11:349
10 ACCELERATING ACCESS
WHO estimates
that, overall,
only about
230 000 people
have access to
ARV therapy in
low- and
middle-income
countries.
LimitationsToo few patients benefitWHO estimates that, overall, only about230 000 people have access to ARVtherapy in low- and middle-incomecountries (half of them in Brazil alone),while about 6 million are estimated to bein need. Building on the commitments madeat UNGASS in June 2001, WHOadvocates that at least 3 million people inneed should be on ARV drugs by 2005.
Measured against this scale of need, thenumber of beneficiaries of the AcceleratingAccess Initiative remains disappointinglylow. The reasons for this are many. Thefailure to reach more people with ARVtherapy in resource limited settings reflectsthe persisting limited availability of fundingfor medicines, diagnostics and infra-structure, as well as continued lack ofaffordability in many countries.
Despite the major reductions in ARVprices, the annual cost of ARV treatmentfor a person living with HIV still exceedsthe annual per capita gross domesticproduct of many least developed countries.
Thus, procurement of ARVs solelythrough domestic financing remains almostimpossible in many countries. However,the weakness of health systems indeveloping countries is also a majorconstraint. Voluntary counselling andtesting for HIV infection is, for example,not widely available, and staff to prescribeand supervise treatments are in short supplyin most developing countries.
Lack of fundingand resourcesVarious financial mechanisms have beenutilized by countries with supplyagreements under the Accelerating AccessInitiative framework. These range fromout-of-pocket payment by individualpatients to full government subsidyinvolving national subsidy schemes,revolving funds, work-based schemes,private insurance, debt relief, and bilateraland multilateral aid. So far only a fewcountries, including Barbados, Chile,Gabon, Morocco, Romania, and Trinidadand Tobago, have been able to commit tofully subsidize the cost of ARV therapy. Theother 13 countries with supply agreementsin place could not do so for lack of funding.
A number of recent global resourcemobilization developments opens the wayfor greater progress in funding increasedaccess to care. In particular, theestablishment in January 2002 of theGlobal Fund to Fight AIDS, TB andMalaria as a result of concerted action bya wide range of stakeholders, includingbilateral donors, the UN system, civilsociety and the private sector offers amajor opportunity to scale up HIV/AIDScare and support treatment. The Fundexplicitly includes provision for drugs andmedicines, including ARVs, within itsscope. The first round of grants announcedby the Global Fund in April 2002 commitsa total of US$616 million in grants (for all
Int. Accelerating Access... 7/01/03, 11:3410
ACCELERATING ACCESS 11
three diseases) for two years forprogrammes in more than 30 countries.About 60% of the first two years offunding will go to HIV/AIDS programmes,and 21 countries will use part of these fundsto purchase ARVs.
The World Bank’s Multi-Country HIV/AIDS Programme for Africa (MAP),initiated in 2001, is providing support forHIV/AIDS prevention, care and treatmentprogrammes, with an emphasis onvulnerable groups, by assistinggovernments, communities and civil societyorganizations in Africa as they implementnational multi-sectoral HIV/AIDSstrategies. About US$400 million a year inconcessional lending, with a correspondinggrant value of US$275 million–300 million,is projected through 2005. A similarinitiative is under way in the Caribbean.Totalling US$155 million, the Multi-Country HIV/AIDS Prevention andControl Project for the Caribbean worksas a five-year loan programme that allowscountries to obtain separate loans orcredits to finance their national HIV/AIDSprevention and control projects. By April2002, about US$40 million had beenallocated to projects, including treatmentaccess, in Barbados and the DominicanRepublic. Several Caribbean countrieshave agreed that parts of these loans maybe assigned to the purchase of ARV drugs.Barbados is the first country that has metthe required criteria and drawn on thesefunds to finance ARV access. The secondphase of MAP will more directly addresstreatment access.
Mobilizing more resources to scale upaccess to HIV care is a major priority forthe UN system. It is estimated that aboutUS$2 billion a year is needed to reach theWHO target of treating 3 million peoplewith ARVs by 2005.
UN capacityOne of the disadvantages of the country-by-country approach adopted by theAccelerating Access Initiative is that it has
been relatively slow and labour intensive.The resources of the UN system haveconsequently been stretched to respond tothe demands for assistance from countriesto participate in the Accelerating AccessInitiative. In some cases, the UN has notbeen able to respond positively to requestsfrom countries in a timely manner, andresources have not been available toprovide technical support once supplyagreements had been reached.
In order to increase the human resourcebase serving the Initiative, 60 consultantswere briefed on the Initiative and used toassist countries with their planning. Thetransfer of the responsibility for technicalassistance for the Initiative from theUNAIDS Secretariat to WHO, inNovember 2001, will also increasecapacity. At the time of writing, fourregional offices of WHO (AFRO, PAHO,SEARO and WPRO) have assigned full-time staff to access to care, and tworegional offices (EMRO and EURO) arebuilding up networks of experts to supportplanning at country level. Nationalprofessional officers dealing with essentialdrugs in the offices of WHO rep-resentatives in anglophone and franco-phone Africa have also been trained and willhelp out in the future, and similar training isforeseen in collaboration with PAHO.National HIV focal points in WHO officesin Africa will be the next group of trainees.
Box 2 Funding mechanisms
A variety of financial mechanisms has been put in place to provide care and support to a largernumber of people living with HIV/AIDS in the countries where the Accelerating Access Initiative ledto supply agreements. Some governments are devoting increased public funds towards preventionand care. For example:
• Côte d’Ivoire, Cameroon, Gabon, Mali, Morocco and Senegal are allocating funds to subsidize accessto ARVs to people who are unable to afford the drugs.
• Burundi and Rwanda have established a revolving fund dedicated to the procurement of HIVmedicines to allow continuous purchasing of drugs.
• Cameroon and Mali have converted part of their debt relief proceeds into a fund for care andtreatment.
• Some governments have invited private companies to subsidize access to drugs for their employeesand families.
Int. Accelerating Access... 7/01/03, 11:3411
12 ACCELERATING ACCESS
Through the
Accelerating
Access
Initiative,
various public
and private
health
providers in
developing
countries have
accessed ARV
drugs and
gained some
experience
with their use.
Regional approaches offer anopportunity to decrease the demand fortechnical support and increase itsefficiency. Recently, progress has beenmarked in developing regional approachesin the Caribbean and in Western Africa.During the last World Health Assembly inMay 2002, CARICOM and ECOWAS metrepresentatives of the pharmaceuticalindustry, and agreed to work on furtherreduction of prices within regionalapproaches. Such regional initiatives offerthe possibility of bulk purchasing, sharedtechnical assistance and joint resourcing,and thus can significantly expand thebenefits of increased access to care.
Capacity buildingThrough the Accelerating Access Initiative,various public and private health providersin developing countries have accessed ARVdrugs and gained some experience withtheir use. Generally, however, thisexperience was not supported bynationally-developed ARV managementguidelines.
The Initiative aims to support capacity,but places the responsibility for it withcountries, as there are no funds in theInitiative for this purpose.
The constraints on capacity building,parallel to those for access to drugs, havemeant that little capacity building hasoccurred.
MonitoringReports on progress with AcceleratingAccess Initiative have been presentedregularly, at the Contact Group and atother relevant consultations, by keypartners in the Initiative. A structuredframework for systematically collectingand presenting data on the Initiative’sperformance has not yet been developed.
WHO and the UNAIDS Secretariat havedeveloped indicators for a wide range ofcare activities, with a large number ofinstitutional partners. These indicators arenow being pilot tested in Cambodia,Ethiopia and Kenya. They will be usedwithin the framework of second generationsurveillance of the HIV epidemic, and couldalso be applied in the evaluation of theInitiative.
Focus on governmentsA limitation of the Accelerating AccessInitiative has been the tendency to workmainly with ministries of health incountries. The intention to engage otherimportant partners has not always beenmet. NGOs and large employers are keypoints of entry for ARVs. In the interestsof inclusiveness and efficiency, all peopleand organizations at country level need tofeel empowered to support treatmentaccess. This shortcoming will be tackledincreasingly in the future, mainly throughwider partnerships.
Lack of promotion ofgeneric pharmaceuticalpartnersDuring the course of the past two years,the collaboration in the AcceleratingAccess Initiative has been focused largelyon the six research-based pharmaceuticalcompanies and the UN. While the Initiativehas been open to generics companies, withsome countries accessing generic ARVs,and while a representative of the genericsindustry recently joined the Contact Group,greater efforts must be made to supportgeneric competition (consistent withinternational agreements) and to engagegeneric producers.
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ACCELERATING ACCESS 13
The Accelerating Access Initiative is notthe only UN activity supporting access tocare for people living with HIV/AIDS.
The potential impact of patents and theAgreement on Trade-Related Aspects ofIntellectual Property Rights (TRIPS) onaccess to medicines has been a continuingconcern for the WHO and the UNAIDSSecretariat. WHO and UNAIDS haveplayed pivotal roles in raising awarenessabout the potential impact of the TRIPSAgreement on access to medicines. For anoverview of these concerns the reader isreferred to the document Globalization andAccess to Drugs: Perspectives on theWTO/TRIPS Agreement published in1998, and one of the 128 publications onthis topic by the WHO since 1998, as wellas the statements of WHO and UNAIDSat the World Trade Organization (WTO)Ministerial Conference in Seattle (1999)and Doha (2001), available on theirrespective websites.
As access to HIV drugs has been one ofthe main concerns in the debate around theinterpretation of the TRIPS Agreement,WHO published, supported by theUNAIDS Secretariat, a study on the patentsituation of HIV-related drugs in 80countries in 1999, which will be updatedin 2002–2003. This document providesimportant information for the procurementof the drugs considered in the study.
In December 2000, the UN systemreleased a call for expressions of interestfrom manufacturers committed toproviding HIV/AIDS products atdifferential prices to developing countries.This call has been repeated twice sincethen. The data collected through thisprocess have been used for two purposes:first, to document the existence of supply
sources of medicines of interest to peopleliving with HIV/AIDS that are difficult tofind on the international market; andsecond, in an effort to improve the qualityof the drugs considered. The annual surveyof Sources and Prices of Selected Medicinesand Diagnostics for People Living withHIV/AIDS, produced by UNICEF, WHO,the UNAIDS Secretariat and Médecins-Sans-Frontières, which provides marketinformation to help procurement agenciesmake decisions on the source of drugs andto help them negotiate better prices, is oneof the outputs of this effort. The 2002edition of this survey was due to belaunched during the InternationalConference on AIDS in Barcelona in July2002.
A second output is prequalification ofthose manufactures that provided detailedinformation on the quality of their productsand whose production facilities successfullypass an inspection site visit. A first list ofprequalified products and suppliers waspublished in April 2002.
A further output is the production ofgeneric quality standards for ARVs. Formost ARVs, such standards are notavailable in the public domain, and thisimpedes the ability of quality assurancelaboratories to provide independentcertification of the quality of the productsthey test.
An important step towards reversingcommon misperceptions about thecomplexity of ARV treatment was thepublication by WHO in April 2002 ofGuidelines for Scaling Up AntiretroviralTherapy in Resource Limited Settings.This guidance on the rational selection anduse of ARV drugs in resource limitedsettings acknowledges the relative
Related Activities
WHO and
UNAIDS have
played pivotal
roles in raising
awareness
about the
potential
impact of the
TRIPS
Agreement on
access to
medicines.
Int. Accelerating Access... 7/01/03, 11:3413
14 ACCELERATING ACCESS
complexity of HIV treatment but addressesthe need to scale up treatment by presentinga framework for selecting the most potentand feasible ARV regimens as part of anexpanded national response. Theframework aims to standardize andsimplify ARV therapy, without comp-romising the quality and outcomes of thetreatment offered, presenting options forfirst and second line regimens that bear inmind that health systems in resource poorsettings often lack sophisticated personneland monitoring facilities. WHO ispromoting the wide acceptance of theseguidelines and adapting them for differentregions. This regional adaptation is ongoing— in South East Asia, the adaptationprocess by SEARO has been completed; in
the Americas, the process by PAHO isalmost complete.
The preparation of these guidelinesprovided an important impetus for theinclusion of 12 ARVs in WHO’s Model Listof Essential Medicines. The Model Listprovides an example from which countriescan develop their own essential medicineslists, according to their priority healthneeds. The inclusion of ARVs in the list willfacilitate their registration in countries byall producers and their procurement bymajor distributors of essential medicines.The list is based on a careful analysis ofcurrent evidence of ARV efficacy indeveloping countries, which shows thatthese medicines can be used effectively andsafely in poor settings.
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ACCELERATING ACCESS 15
Lessons LearnedAfter some two years of work on theAccelerating Access Initiative in countries,it has become clear to all partners thatincreasing access to treatment is a dauntingtask that has only just begun. Millions ofpeople will need to gain access to ARVtherapy in the coming years. WHOadvocates that, by 2005, 3 million peopleshould have access to ARVs. A number oflessons have been learned that can furthersupport efforts to scale up access.
First and foremost, access to ARVtherapy is possible in resource poorsettings. Building on the results of theUNAIDS/WHO Drug Access Initiative, theexperience of the Accelerating AccessInitiative has further reinforced thefeasibility of delivering ARV treatment indeveloping countries. A number ofdeveloping countries have committedthemselves to universal access.
Advocacy for access to ARVs facilitatesefforts to introduce comprehensive care forpeople living with HIV/AIDS. For example,Uganda, Côte d’Ivoire and Senegal haveintroduced national policies for preventionof opportunistic infections along with theintroduction of ARVs. National authoritiesoften favour access to ARVs because oftheir dramatic impact on survival and oftenlink other important care interventions toARVs.
Clear and transparent information aboutdrug pricing facilitates the development ofplans for access to care, fosteringpredictability of implementation costs and,in turn, greater specificity in fundraisingefforts.
Countries are committed to scaling uptreatment urgently. At the UNGASS, allUN Member States committed themselves
to expanding access to comprehensivecare, including ARVs. Within theAccelerating Access Initiative, governmentshave waived import tariffs and taxes onHIV medicines and mobilized domesticresources to increase procurement.
Although they have decreasedsignificantly in many cases, the prices ofARVs in developing countries remain toohigh in relation to local purchasing power.Despite the major reductions in ARVprices, the annual cost of ARV treatmentfor a person living with HIV still exceedsthe annual per capita gross domesticproduct of many least developed countries.Thus, procurement of ARVs solely throughdomestic financing remains almostimpossible in many countries. A massiveincrease in international financial supportfor HIV/AIDS care is crucial. While fargreater investments in health and socialservices infrastructure are needed toexpand access to treatment on a massivescale, many countries have underutilizedhealth system capacity that, but for lackof financing and affordability, could beused to expand treatment today.
Broader partnerships are essential toscale up access to care. For example, whenNGOs dealing with HIV/AIDS wereinvolved in the Accelerating AccessInitiative to support treatment prepared-ness, such as in Morocco, the level ofknowledge about and interest in accessingtreatment improved considerably. In manycountries, NGO advocacy has advancedpolitical commitment to treatment. In somecountries, such as Burundi, Côte d’Ivoire,Rwanda and South Africa, employers havesupported treatment access among theirworkforces.
The experience
of the
Accelerating
Access
Initiative has
further
reinforced the
feasibility of
delivering ARV
treatment in
developing
countries.
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16 ACCELERATING ACCESS
ConclusionThe Accelerating Access Initiative wasestablished in May 2000 to help increaseaccess to HIV/AIDS care and treatment indeveloping countries.
The Initiative, building on the politicalcommitment of governments, intensetreatment advocacy of civil society andearlier UN initiatives, has helped the worldto move from inertia to action in workingon improving access to HIV care andtreatment in developing countries. It hasencouraged many countries to think aboutand plan for expanded efforts in HIV careand support. It has helped all stakeholdersconcerned with access to HIV/AIDS careand treatment to learn about newpossibilities. It has also catalyzed newefforts – by the countries themselves,international donors, private sectorenterprises, NGOs, and others – to extendcare to more of those living with HIVinfection in the developing world.
As a result of Accelerating Access andrelated efforts, with companies independ-ently entering into discussions withcountries and other purchasers, the pricesof ARV medicines have declinedsignificantly in developing countries in thepast two years. In some cases the prices ofthese medicines have decreased by morethan 90% during this time. These pricereductions have acted as a catalyst instimulating efforts to increase access toARVs in developing countries. Never-
theless, to date few people have been ableto benefit from these price reductions.
While further price reductions will leadto an increase in the number of people onARV therapy, it is clear that significantlyexpanding such access will require workon the other barriers to care and treatmenttoo.
This will require two main approaches:unequivocal and ongoing politicalcommitment from national governments;and greater financial resources fromnational resources and the internationalcommunity (including the new Global Fundto Fight AIDS, TB and Malaria) to fundthe drugs and diagnostics needed, and tostrengthen health infrastructure anddelivery systems in developing countries.In addition, greater engagement of allstakeholders (including people living withHIV/AIDS and the private sector), guid-ance on the rational use of treatment, andcontinued investment in the developmentof improved medicines will be needed.
Clearly, there is still much more workto be done, given the scope of thechallenge. While in absolute terms thenumbers are still small, we have seenencouraging progress in the past two yearsand a steady increase in patients receivingARV treatment through AcceleratingAccess and related initiatives.
This experience offers strong hope forthe future.
We have seen
encouraging
progress in the
past two years
and a steady
increase in
patients
receiving ARV
treatment
through
Accelerating
Access and
related
initiatives.
Int. Accelerating Access... 7/01/03, 11:3416
ACCELERATING ACCESS 17
United Nations General Assembly,Twenty-sixth Special Session, Doc:A/s-26/L.2, adopted 27.06.2001, NewYork.
UNAIDS. Accelerating Access to HIV/AIDS Care, Treatment and Support.Background Paper. September 2001.w w w. u n a i d s . o r g / p u b l i c a t i o n s /d o c u m e n t s / h e a l t h / a c c e s s /AAprogress1001.doc
UNAIDS/WHO. Sources and Prices ofSelected Medicines and Diagnostics forPeople Living with HIV/AIDS, May2002. www.who.int/medicines
WHO. HIV/AIDS Drugs Pre-qualificationPilot Procurement, Quality and SourcingProject: Access to HIV/AIDS Drugs ofAssured Quality. www.who.int/
medicines/organization/qsm/activities/pilotproc/pilotproc.shtml
WHO. Globalization and Access to Drugs:Perspectives on the WTO/TRIPSAgreement. Geneva 1998. WHO/DAP/98.9. www.who.int/medicines
WHO. Scaling Up Access to AntiretroviralTherapy. Guidelines for a Public HealthResponse. Geneva, April 2002.www.who.int/hiv_aids
WHO/UNAIDS. Key Elements in HIV/AIDS Care and Support. Draft WorkingDocument, 8 September 2000.www.who.int/hiv_aids
WHO/WTO. Report of the Workshop onDifferential Pricing and Financing ofEssential Drugs. April 2001, Hosbjor,Norway. www.who.int/medicines
Further Reading
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ACCELERATING ACCESS 19
A Joint Statement of IntentBuilding on the work undertaken by theJoint United Nations Programme on HIV/AIDS (UNAIDS), its Cosponsors and otherpartners worldwide in responding to thegrowing demand for care and treatmentof HIV/AIDS-related illnesses indeveloping countries, a new effort is beingundertaken to enhance progressively thecapacity of countries to increase accessto, and use of, sustainable, comprehensiveand quality HIV/AIDS interventionsacross the entire spectrum of prevention,treatment, patient care and support(including prevention of perinataltransmission).
Five pharmaceutical companies —Boehringer Ingelheim GmbH, Bristol-Myers Squibb; Glaxo Wellcome; Merck &Co., Inc.; and F. Hoffmann-La Roche Ltd.— are responding to calls from UNSecretary-General Kofi Annan (inlaunching the International Partnershipagainst AIDS in Africa, in December1999); Dr Gro Harlem Brundtland,Director-General of the World HealthOrganization (in her address to the WHOExecutive Board in January 2000), whereshe invited the pharmaceutical companiesto ‘take a fresh and constructive look athow we can increase access to relevantdrugs’, and to the invitations of Dr PeterPiot, Executive Director of UNAIDS,James D. Wolfensohn, President of theWorld Bank, Carol Bellamy, ExecutiveDirector of the United Nations Children’sFund, and Nafis Sadik, Executive Director,United Nations Population Fund, to theprivate sector to engage in partnerships forexpanding the global response to HIV/AIDS.
Accelerating access to HIV/AIDS careand treatment in developing countries
ANNEX 1
The five companies have begunconstructive discussions with UNAIDS,WHO, the World Bank, the United NationsChildren’s Fund (UNICEF), and the UnitedNations Population Fund (UNFPA) toexplore practical and specific ways ofworking together more closely toaccelerate access to HIV/AIDS-relatedcare and treatment in developing countries.This endeavour is expected to expand toinclude other partners from all sectors.
Participants acknowledge thataffordability of HIV/AIDS-related care andtreatment is an issue in developingcountries — though only one among manyobstacles to access including social/political/structural and economic issues,healthcare financing, physical barriers, andinformation gaps — and are willing towork with committed governments,international organizations and otherstakeholders to find ways to broadenaccess while ensuring rational, affordable,safe and effective use of drugs for HIV/AIDS-related illnesses. The companies,individually, are offering to improvesignificantly access to and availability ofa range of medicines.
Intended to benefit people in developingcountries, this public/private co-operation
■ is designed to accelerate theirsustained access to, and increase theiruse of, appropriate, good qualityinterventions for the prevention,treatment and care of HIV/AIDS-related illnesses, and the preventionof perinatal transmission of HIV.
■ strives to ensure that care andtreatment reach significantly greaternumbers of people in need, throughnew alliances involving committed
Int. Accelerating Access... 7/01/03, 11:3419
20 ACCELERATING ACCESS
governments, private industry, theUN system, development assistanceagencies, non-governmental organ-izations (NGOs) and people livingwith HIV/AIDS.
■ will be implemented in ways thatrespond to the specific needs andrequests of individual countries, withrespect for human rights, equity,transparency and accountability.
The following principles reflect acommon vision of how the HIV/AIDSepidemic can more effectively be tackledin developing countries:
(i) Unequivocal and ongoing politicalcommitment by national governmentsis essential for successful efforts toreduce the impact of HIV/AIDS inline with poverty reduction andbroader development strategies.
(ii) Strengthened national capacity,including well-designed HIV/AIDSprevention and care strategiesand a strengthened health-careinfrastructure, is crucial for deliveringcare and treatment to people withHIV/AIDS on an equitable basis.
(iii) Engagement of all sectors of nationalsociety and the global community –including governments of developingand industrialized donor countries,international NGOs, industry, othersegments of civil society (particularlypeople living with HIV) andmultilateral organizations – is essentialin facilitating access to treatment ofHIV/AIDS-related illnesses.
(iv) Efficient, reliable and securedistribution systems are necessary toensure that medical supplies and otherconsumables procured by the publicsector or NGOs are made available
to people who need them at theappropriate contact points withinhealth systems.
(v) Significant additional funding fromnew national and internationalsources, commensurate with thehealth challenges posed by the HIVepidemic, is necessary for long-termsuccess, so that current health andsocial sector priorities can bemaintained.
(vi) Continued investment in research anddevelopment by the pharmaceuticalindustry on innovative newtreatments for HIV/AIDS and otherdiseases affecting the developingworld – the best hope for new andbetter future medicines and vaccines– is critical to expanding the globalresponse to HIV/AIDS and toadvancing world health. Therefore,intellectual property rights should beprotected, in compliance withinternational agreements, sincesociety depends on them to stimulateinnovation.
This public/private co-operation isintended to increase the proportion ofpeople living with HIV/AIDS in thedeveloping world who have safe, equitable,sustained and affordable access to care andtreatment. As a practical response to thecall for multi-sectoral action in the face ofthis global health challenge, it is animportant step in a longer-term process ofincreasing the access to care of women,men and children in developing countries.It aims to contribute to the InternationalPartnership against AIDS in Africa, as wellas efforts to curb the spread of HIV andmitigate its impact in other continents and,more broadly, to support the internationaldevelopment agenda.
Int. Accelerating Access... 7/01/03, 11:3420
ACCELERATING ACCESS 21
Countries that have expressed interest inAccelerating Access (as of March 2002)
ANNEX 2
Continent Country
Africa Algeria
Angola
Benin
Botswana
Burkina Faso
Burundi
Cameroon
Cap Vert
Central African Republic
Chad
Congo
Côte d’Ivoire
Ethiopia
Gabon
Gambia
Ghana
Guinea
Guinea-Bissau
Kenya
Liberia
Malawi
Mali
Mauritius
Morocco
Niger
Nigeria
Rwanda
Sierra Leone
Senegal
Seychelles
Swaziland
Togo
Tunisia
Uganda
Mozambique, Namibia, Lesotho, South Africa
United Replublic of Tanzania, Zambia, Zimbabwe
Status
Mission being planned
No follow-up yet
Plan completed and supply agreements in place
Planning completed, discussions on supply agreements finalized outside the AAI framework
Plan completed and supply agreements in place
Plan completed and supply agreements in place
Plan completed and supply agreements in place
Planning ongoing supported by ECOWAS
Plan completed, no supply agreements sought by government at this stage
Plan completed, supply agreements partly in place
Plan completed and supply agreements in place
Plan completed and supply agreements in place
Plan completed, no supply agreements sought by government at this stage
Plan completed and supply agreements in place
Plan completed and discussions on supply agreements awaited
Planning ongoing supported by ECOWAS
Plan completed and discussions on supply agreements awaited
Planning ongoing supported by ECOWAS
Plan completed, no supply agreements sought by government at this stage.
Planning ongoing supported by ECOWAS
Plan completed. Discussions on supply agreements ongoing outside the AAI framework
Plan completed and supply agreements in place
No follow-up yet
Plan completed and supply agreements in place
Planning ongoing supported by ECOWAS
Plan completed and discussions on supply agreements awaited
Plan completed and supply agreements in place
Planning ongoing supported by ECOWAS
Plan completed and supply agreements in place
No follow-up yet
Plan completed, no supply agreements sought by government at this stage
Planning ongoing supported by ECOWAS
Plan completed and discussions on supply agreements awaited
Plan completed and supply agreements in place
These countries are members of SADC and have so far not decided whether to start collaboration
with AAI. In some of these countries there is important use of ARVs in the private sector.
Int. Accelerating Access... 7/01/03, 11:3421
22 ACCELERATING ACCESS
Continent Country
Latin America and Caribbean Bahamas
Barbados
Belize
Chile
Costa Rica
Guatemala
El Salvador
Honduras
Jamaica
Mexico
Nicaragua
Panama
Trinidad and Tobago
Venezuela
Antigua and Barbuda, Dominica, Grenada, Guyana, Haiti, Montserrat,
St Kitts and Nevis, St Lucia, St Vincent/Grenadines, Suriname
Europe Georgia
Belarus
Moldavia
Romania
Ukraine
Asia China
Indonesia
Malaysia
Thailand
Viet Nam
Middle East Jordan
Egypt
Oman
Lebanon
Syria
Status
Plan completed and supply agreements in place
Plan completed and supply agreements in place
No follow-up yet
Plan completed and supply agreements in place
No follow-up yet
No follow-up yet
Plan completed and discussions on supply agreements ongoing
Plan completed and supply agreements in place
Plan completed and supply agreements in place
Plan completed and discussions on supplies progressing with some companies
No follow-up yet
No follow-up yet
Plan completed and supply agreements in place
Plan completed and discussions on supply agreements awaited
These countries are members of CARICOM and are planning for access to ARVs on a
regional basis
Planning ongoing
No follow-up yet
Plan completed and opening of discussion on supply agreement awaited
Plan completed and supply agreements in place
Plan completed and discussions on supply agreements ongoing
Planning ongoing
A final decision whether to pursue improving access to ARVs through AAI is pending
A final decision whether to pursue improving access to ARVs through AAI is pending
The Thai government opted to continue its planning outside the AAI framework
Plan completed, no supply agreements sought by government at this stage
Follow-up by EMRO started
Follow-up by EMRO started
Follow-up by EMRO started
Plan completed and discussions on supply agreements awaited
Follow-up by EMRO started
Cont’d
AAI = Accelerating Access Initiative
Int. Accelerating Access... 7/01/03, 11:3422
ACCELERATING ACCESS 23
IntroductionThe Accelerating Access Initiative wasestablished in May 2000 to help increaseaccess to HIV/AIDS care and treatment indeveloping countries. The Initiative is thefirst broad-based public / privatepartnership of its kind. It is a partnershipof five United Nations organizations(UNAIDS Secretariat, WHO, UNICEF, theUN Population Fund and the World Bank)and six research-based pharmaceuticalcompanies (Abbott Laboratories;Boehringer-Ingelheim; Bristol-MyersSquibb; GlaxoSmithKline; F. Hoffmann –La Roche; and Merck & Co., Inc.).
In April 2001, the original fiveAccelerating Access companies, nowjoined by Abbott Laboratories, announcedadditional steps to improve access to HIVand HIV-related medicines and diagnosticsfor poor countries.
The purpose of this interim report is toestimate the number of patients who havebeen treated with ARVs supplied by the sixcompanies in the countries of Africa, thegeographic region most affected by theHIV/AIDS epidemic and the region inwhich early efforts by the Initiative wereconcentrated.
Currently, the only available systematicand reliable data for the companies to useto estimate the number of patients treatedare the quantity of drug units supplied tothe countries. These data, however, areconfidential and cannot be shared betweencompanies. For this reason, AxiosInternational, as a third party withexperience in the area of HIV/AIDS carein the developing world and operatingunder an agreement of confidentiality,
received and analyzed the data from thecompanies and compiled results acrosscompanies.
Method of analysisThe data provided are either in packs,tablets or grams of active substancessupplied each quarter. In addition, manyproducts exist as multiple dosages or packsizes. For the sake of consistency, a singleformula relying on the weight of activedrug is applied to convert the figures intoan estimated patient number for eachquarter.
Once these data are converted into theestimated number of patients for eachproduct per quarter, the data are pooledas follows:
■ It is assumed that all patients take atleast two Nucleoside ReverseTranscriptase Inhibitors (NRTI) andall patients follow the standard dailydosages. It is further assumed thatno patients are taking monotherapy.A proportion of the patients aretaking, in addition to their twoNRTI’s, one Non-Nucleoside ReverseTranscriptase Inhibitor (NNRTI) orone Protease Inhibitor (PI). As it is acommon practice to combine Norvir®(ritonavir) with Crixivan® (indinavirsulfate) or with Invirase® /Fortovase® (saquinavir) the analysistook this aspect into consideration. Thecombination of Norvir as a booster toanother PI was considered as one PI.
■ All NRTI figures for data units (perproduct and per quarter) were addedand pooled and divided by two to
Estimated numbers of African patientson antiretroviral therapy
ANNEX 3
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24 ACCELERATING ACCESS
obtain the number of patients on2 NRTI. Countries are divided byregions. For Africa, four regions arecategorized, i.e. North Africa, WestAfrica, Southern Africa and EastAfrica. The assumption is that allpatients are on at least 2 NRTI. Someare on double combinations with2 NRTI only and the others are ontriple combination 2 NRTI + 1 PI orNNRTI. Hence the final figures ofpooled NRTI obtained represent thetotal estimated number of patients onARVs.
■ NNRTI and PI data are then pooledand matched with the NRTI figures.The results are therefore presented perquarter and for the whole of Africaand by region as follows:
– Total estimated number of patientson ARVs = patients on at least2 NRTI.
– Estimated number of patients ondouble combination of 2 NRTI.
– Estimated number of patients ontriple combination including2 NRTI+1 NNRTI; 2 NRTI+1 PI.
Breakdown Q3-00 Q4-00 Q1-01 Q2-01 Q3-01 Q4-01 Q1-02
Double combination 5887 5866 6863 9616 7792 10 864 12 669
Triple combination 3377 5174 8371 12 788 18 751 21 790 22 882
Estimated number of patients 9264 11 040 15 234 22 404 26 543 32 654 35 551
Table A3.1 Africa double and triple combination
Figure A3.1 Africa: Estimated number of patients on at least 2NRTIDouble and Triple Combination Therapies Breakdown
Int. Accelerating Access... 7/01/03, 11:3424
ACCELERATING ACCESS 25
At the end of March 2002, Axiosestimates that the six companies involvedin Accelerating Access supplied treatmentto more than 35 500 people in Africa, afour-fold increase over the past 18 months.In addition, the data show that the
proportion of patients on triplecombination therapy over that periodincreased from one third to nearly twothirds, which indicates a concomit-ant increase in the quality of ARVtreatment.
Figure A3.2 Africa by regionEstimated number of patients on at least 2NRTI
The figures above show that the Eastand West Africa regions had the greatestincrease in the rate of numbers of patientsaccessing ARVs. In addition, results forSouthern Africa reveal an anomalousobservation that the number of patientstreated actually decreased between Q4 ’01
and Q1 ’02. Whether this is due to normalwholesaler/distributor buying patterns (seethe similar observation between Q4 ’00 andQ1 ’01) or to other factors will requirefurther investigation.
Q2 ’02 results will be importantadditions to these trend lines.
Regions Q3-00 Q4-00 Q1-01 Q2-01 Q3-01 Q4-01 Q1-02
West Africa 1554 1094 2778 7032 7632 8189 11 064
Southern Africa 6670 8367 8530 11 512 13 549 17 789 16 396
East Africa 866 895 3438 3093 4714 6195 7614
North Africa 174 684 488 767 648 481 477
Estimated number of patients 9264 11 040 15 234 22 404 26 543 32 654 35 551
Table A3.2 Africa by region
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26 ACCELERATING ACCESS
LimitationsThe fact that this analysis was based ondrug units supplied and converted intoestimated patient numbers implies anumber of advantages and limitationscompared to formal country surveys.
■ The data are collected precisely andconsistently as they represent unitssupplied and data sales. The analysis istherefore underpinned by reliable data.
■ The calculated number of patientsrepresents only an estimate of thenumber of patients treated by ARVssupplied by the six companies in theAccelerating Access Initiative. It doesnot represent an estimate of the totalnumber of patients treated in Africaas it does not take into account thepatients treated with ARVs suppliedby other companies.
■ It is unlikely that all patients took theexact recommended daily dosages. It
is equally unlikely that patients tookhigher doses than those recom-mended. Usually the problem isincomplete daily dosage. This meansthat the actual number of patients islikely to be higher than thatcalculated.
■ It is possible that a number of patientsare taking one ARV as monotherapyor a combination of 1 NRTI and 1 PIor other combinations. It is estimatedthat this number is limited. However,this also implies that the actualnumber of patients is likely to behigher than the calculated one.
■ Paediatric use has not been includedin the analysis given the difficulty inestimating infant dosages. Usually,these dosages are by the child’s bodyweight, which requires knowledge ofthe age of the child. The absenceof paediatric treatment from theanalysis does contribute to theunderestimation of the actual numberof patients.
WAF = West Africa
Benin
Burkina Faso
Cameroon
Central African Republic
Congo
Gabon
Gambia
Ghana
Guinea
Ivory Coast
Mali
Niger
Nigeria
Senegal
Sierra Leone
Togo
Definition of the regions
SAF = Southern Africa
Angola
Botswana
Lesotho
Mozambique
Namibia
South Africa
Swaziland
Zambia
Zimbabwe
NAF = Northern Africa
Algeria
Chad
Egypt
Libyan Arab Jamahiriya
Morocco
Tunisia
EAF = East Africa
Burundi
Djibouti
Ethiopia
Kenya
Madagascar
Malawi
Mauritius
Rwanda
Seychelles
United Republic of Tanzania
Uganda
Int. Accelerating Access... 7/01/03, 11:3426
ACCELERATING ACCESS 27
■ It is widely admitted that a substantialproportion of patients (20–40%) doesnot regularly take the medications dueto a variety of factors (e.g. drug“holidays”, structured therapyinterruptions, non-adherence toprescribed drug regimens). Thisimplies that the actual number ofpatients is possibly substantiallyhigher than the calculated one.
■ Commonly, a proportion of the drugssupplied does not actually get to thepatients and is wasted either duringdistribution or when the patientsswitch to another combinationtherapy. The estimated number ofpatients does not take into accountthis fact and tends to overestimate theactual number of patients.
■ It is also assumed that a proportionof the amount of drugs sold into acountry simply acts to fill thedistribution pipeline in that country.It is further assumed that thisproportion is roughly equal fromquarter to quarter and, therefore, theincreases seen in estimated numbersof patients on therapy from quarterto quarter are due to actual increasesin the estimated numbers of patientsaccessing therapy.
ConclusionMore than half of the countries involvedin the Accelerating Access Initiative are inAfrica, which provides an importantexample of how this Initiative hascatalyzed efforts to extend HIV care,treatment and support. According to thedata in this interim report – compiled on
behalf of the six companies involved inAccelerating Access – which are consistentwith UN figures, more than 35 500 peoplein Africa were being treated with ARVssupplied by the six companies by the endof March 2002, a four-fold increase in 18months. In addition, the data show thatthe proportion of patients on triplecombination therapy over that periodincreased from one third to nearly twothirds, which indicates a concomitantincrease in the quality of ARV treatment.
Even if the estimated numbers in thisinterim report do not exactly represent thetotal number of patients treated withARVs in Africa, they do provide relevantinformation on:
■ the trends in the quality of treatmentprovided, and
■ the substantial increase in the patientnumbers since the AcceleratingAccess Initiative was launched.
Given that most of the limitations implythat the actual number of patients is higherthan the number calculated in this analysis,it is safe to consider that the numbersconstitute a conservative estimate of thepatients actually treated with ARVssupplied by the six companies in theAccelerating Access Initiative. A 20–50%increase in the calculated number wouldlikely be closer to the real figure
Clearly, there is still much more workto be done, given the scope of thechallenge. While in absolute terms thenumbers are still small, we have seenencouraging progress in the past 18 monthsand a steady increase in patients receivingARV treatment in Africa throughAccelerating Access and related initiatives.
Int. Accelerating Access... 7/01/03, 11:3427
ND: no
disc
ussio
n; S:
syrup
formu
lation
disc
ussed;
no a
dult
formu
lation
sup
plied
; IP: in
prog
ress;
NA:
no p
rice
avail
able; B
lank
cell:
no s
upply
agreeme
nt u
nder t
he A
ccele
ratin
g Access
Initia
tive
for t
his d
rug
in this
coun
try o
n record. (1)
These
drug
s are
billed
in
Swiss
Francs.
In this
table
the
excha
nge
rate
used
is
1.7 S
wiss
Fran
cs to t
he U
S$; (2)
The
hard g
el for
mulat
ion o
f SQ
V shou
ld be
used
only
in comb
inatio
n with r
itona
vir a
s bo
oster
drug
(100
0mg/10
0 mg
BID).
The
price
of riton
avir
is no
t inc
luded
in
the
price
quo
ted; (3)
Clinic
al stu
dies
indica
te that,
when
used
with r
itonavir
as
booster
drug,
the
dose o
f ind
inavir
can
be
decre
ased
to
2*80
0 mg
; (4) W
hen
used
with
rito
navir
as
booster
drug
the
dose o
f saqu
inavir
can
be
redu
ced
to 2
*100
0 mg
or
1*16
00 m
g; (5)
This
price
includ
es a
volu
me-driv
en d
iscou
nt; (
6) N
ot y
et reg
istered
— r
egistratio
n on
going
; (7) S
ource
: Sou
rces
and
price
s of
selec
ted d
rugs a
nd d
iagno
stics
for p
eople
living
with
HIV/
AIDS.
UNICE
F, UN
AIDS
secre
taria
t, WHO
, MSF, G
eneva,
May
2002
. Whil
e some
drugs includ
ed in
this
row
have b
een
pre-q
ualifi
ed b
y WHO
, the
qua
lity
of the
prod
ucts
mention
ed h
ere
has
not
necessa
rily
been
evalua
ted; (8)
Price
for 2
*100
mg
riton
avir, a
s bo
oster
of othe
r protease inh
ibitors.
Pric
es o
f ARV
s (U
S$/d
ay)
in t
he A
ccel
erat
ing
Acce
ss Ini
tiat
ive
This
table
con
tains
infor
matio
n ab
out ad
ult fo
rmula
tions a
nd d
osages o
nly
ANNE
X 4
Sub-Saha
ran Afr
ica
Chile
Moroc
co
Barbad
os
Jamaic
a
Trinid
ad and
Toba
go
Hond
uras
Roma
nia
Ukraine
Media
n price
offe
red by
gen
eric
industry
(FOB
)*
1.60 CIF
1.60
1.60
1.60
1.60
1.60
7.30
2.22
0.9
0.64 CIF
0.64
0.64
0.64
0.64
0.64
1.66
S 3.20
0.46
2.00 CIF
2.00
2.00
2.00
2.00
2.00
2.60
S 2.00 (5)
1.38
3.80 CIF
6.60
ND (6)
3.96
ND 3.96
ND 6.80
ND NA
6.60 CIF
9.30
ND (6)
ND ND ND ND 15.0
ND NA
8.70 CIF
9.60
ND (6)
ND ND ND ND 14.8
ND NA
0.85 (2) D
DU
2.37
0.85 DD
U
1.25 DD
U
0.85 DD
U
0.85 DD
U
0.85 DD
U
4.8 (5
)
IP 1.12
0.15 (2) D
DU
3.29
0.75 DD
U
1.00 DD
U
0.75 DD
U
0.75 DD
U
0.75 DD
U
5.2 (5
)
IP 0.20
0.44 CIF
NA
1.37 CIF
5.18
2.52
IP IP IP IP 1.37
IP 1.55
1.20 CIF
2.47
1.20
1.20
1.20
1.20
1.20
1.58
IP 0.54
0.23 (8) F
OB
NA
1.37 FO
B
NA
1.64 CIF
4.6 2.82
IP IP IP IP 1.64
IP 2.40
2.35 CIF
4.80
6.62 CIF
NA
6.47 (5) C
IF
8.2
ZDV—
600 m
g/d 3TC—
300 m
g/d ZDV/3
TC—2/d AB
C—600 m
g/d ZDV/3
TC/ABC—
2/d
AMP—
2400mg
/d
ddI—
400 m
g/d
d4T—
80 mg/d
ddC (
1)—2.2
5 mg/d
EFV—
600 m
g/d NVP—
200 m
g/d RTV—
200 m
g/d
LPV/R
—6/d
IND—
2400 m
g/d (3
)
SQV H
ard Gel (1)
—2000mg
/d (with RTV)
(2)SQV S
oft Gel (1)
—3600mg
/d (4)
NFV (
1)—2500mg
/d
Int. Accelerating Access... 7/01/03, 11:3428
Offe
rs for
ant
iret
rovi
ral dr
ugs
by p
ropr
ieta
ry c
ompa
nies
for
dev
elop
ing
coun
trie
sAN
NEX
5
Com
men
t
The price
of r
itonavir
is give
n for
its use as b
ooste
r drug
to
be u
sed
with ano
ther protea
se in
hibito
r. No
adju
stmen
t to the do
se and
cost
of othe
r protea
se in
hibito
rs ha
s been ma
de. A
s of 3
May 200
2orga
nization
s in the fol
lowing
cou
ntrie
s have accesse
d lop
inavir
and
riton
avir
at re
duced price
s: Alg
eria,
Ben
in, Botsw
ana,
Burund
i,Camb
odia,
Cam
eroon
, Côte d
’Ivoir
e, Djito
uti, Ga
bon,
Haiti, K
enya,
Mauritius, N
amibi
a, Rw
anda
, Senegal, Si
erra Leon
e, South Afr
ica, T
unisia,
Ugan
da, Z
imba
bwe
Nevir
apine
is availa
ble also
free of c
harge specific
ally for
use in
the
preven
tion of
mother-to
-child
tran
smiss
ion th
roug
h the V
iramu
neDo
natio
n Prog
ramm
e (ww
w.vir
amun
e-don
ation
-program
.org)
As of M
ay 15,
2002
, the
pub
lic se
ctor i
n Sene
gal, Be
nin, Ivory Coa
st,Rw
anda
, Gab
on, C
had,
Repu
blic o
f Con
go, M
ali, C
ameroo
n, Togo
, Burun
di,Gu
inea an
d Bu
rkina
Faso ha
ve availed
them
selve
s of
this
offer.
Nume
rous organ
izatio
ns in
the priva
te secto
r (inc
luding
NGO
s,comm
unities of fait
h, priva
te em
ployers,
retail ph
arma
cies)
inBo
tswan
a, Kenya,
Lesotho,
Malaw
i, Mo
zamb
ique,
Nami
bia, S
outh Africa,
Swazila
nd, U
gand
a, Un
ited
Repu
blic of
Tanzan
ia, Zam
bia a
ndZim
babw
e ha
ve a
lso availed
them
selve
s of
this
offer
As of J
une 20
02, s
ome 95
arra
ngem
ents
have been conclud
ed co
verin
g31
cou
ntrie
s for th
e supp
ly of
prefe
rential
ly price
d AR
Vs. T
he cou
ntrie
sare B
arba
dos,
Benin
, Botsw
ana,
Burkina
Faso,
Burund
i, Came
roon
,Central A
frican Re
publi
c, Ch
ad, C
ongo
(Brazza
ville)
, Chil
e, Eritrea,
Gabo
n, Gu
inea (Co
nakry),
Hait
i, Ho
nduras, Ivory
Coast, Jam
aica,
Kenya,
Mali,
Morocco
, Nam
ibia,
Nigeria
, Rom
ania, Rwa
nda,
Senegal, South Afr
ica,
Tanzan
ia, Togo,
Trinid
ad and
Tob
ago,
Ugan
da, U
krain
e an
d Un
ited
Repu
blic of
Tanzan
ia
Elig
ible
org
aniz
atio
ns
Governme
nts,
NGOs
, UN
syste
m orga
nization
s, an
dothe
r nation
al an
d int
erna
tiona
l health
institutio
ns
In sub-Saha
ran Afr
ican coun
tries and
other co
untries
identifie
d as lo
w-inc
ome in
the W
orld
Bank
Classi
fication
of E
cono
mies, b
oth priva
te an
d pu
blic
secto
r orga
nisation
s that are able
to p
rovid
e eff
ectiv
e,susta
inable
and
med
ically so
und care and
treatm
ent o
fHIV/AID
S are elig
ible
Both p
rivate an
d pu
blic secto
r orga
nisation
s that are
able
to provid
e eff
ectiv
e, susta
inable
and
med
ically
soun
d care and
treatm
ent o
f HIV/
AIDS are eligib
le
Governme
nts,
aid organ
izatio
ns, c
harities
, intern
ation
alan
d UN
agencies
and
inter
natio
nal p
urchase fun
ds. In
sub-Saha
ran Afr
ica, t
he offe
r is o
nly availa
ble to
emplo
yers
who
can
deliver care an
d tre
atme
nt d
irectl
yto th
eir st
aff.
All organ
izatio
ns m
ust s
upply
the
prefe
rential
ly price
d prod
ucts
on a not fo
r profit basis
Pric
e pe
r da
y in
US$
(FOB/
CIF/
DDU)
(DDD
)
0.23 (FO
B)(2*1
00mg
)1.3
7 (FO
B)(2*3
caps)
1.20 (CI
F)(2*2
00 m
g)
0.85 (DDU
)(4*1
00 m
g)0.1
5 (DDU
)(2*4
0 mg
)
3.80 (CI
F)(2*3
00 m
g)0.6
4 (CI
F)(2*1
50 m
g)1.6
0 (CI
F)(2*3
00 m
g)2.0
0 (CIF)
(2*1
tabl)
6.60 (CIF)
(2*1
tabl)
Coun
trie
s ta
rget
ed
Africa
plus
Afgh
anistan
, Ban
glade
sh, B
hutan,
Camb
odia, C
ape V
erde
, Hait
i, Kir
ibati,
Lao
Peop
le’s
Demo
cratic Repub
lic, M
aldive
s, My
anma
r, Ne
pal,
Samo
a, Solom
on Is
lands, T
uvalu
, Van
uatu, Yem
en
Sub-Saha
ran Afr
ica plus
other co
untries id
entified
as lo
w-inc
ome in
the W
orld
Bank
Clas
sifica
tion of
Econ
omies
. For co
untries id
entified
as l
ower-
midd
le an
d up
per-m
iddle
incom
e in
the W
orld
Bank
Clas
sifica
tion of
Econ
omies
, pub
lic se
ctor
price
s are ne
gotia
ted on a case-by case basis,
bilaterall
y or th
roug
h the AA
I
Lowe
st price
for s
ub-Sa
haran Afr
icaDe
velop
ing co
untries outsid
e of
sub-Saha
ran Afr
icane
ed to
disc
uss p
rices on a case-by-c
are ba
sis
Least De
velop
ed C
ountrie
s (LD
Cs) plu
s sub-
Saha
ran Afr
icaFo
r midd
le inc
ome de
velop
ing co
untries pub
licsecto
r price
s are ne
gotia
ted o
n a case-by-c
ase
basis
, bila
terall
y or th
roug
h the AA
I
Prod
ucts
riton
avir
lopina
vir/ri
tona
vir
nevir
apine
didan
osine
stavudin
e
abacavir
lamivu
dine
zidovud
inelam
ivudin
e/zid
ovud
ineab
acavir/
lamivu
dine/zid
ovud
ine
Com
pany
Abbo
tt
Boeh
ringer I
ngelh
eim
Bristol-
Myers S
quibb
GlaxoSmi
th-Klin
e
Int. Accelerating Access... 7/01/03, 11:3429
Com
men
t
Clinic
al stu
dies s
uggest
that w
hen used
with
ritona
vir as b
ooste
r drug,
the do
se of ind
inavir
can
be de
creased
to 2*8
00 m
g
Roma
nia also
ben
efits
from
the low
HDI pric
es as a
n exception
, in
respon
se to
the Go
vernme
nt’s
comm
itmen
t to
provide
univ
ersal
coverage to
all pa
tients (m
ostly
chil
dren
) who
req
uire AR
Vtherap
y
Price
s are in
Swiss
Francs (CHF
) and
were converted
in U
S$ u
sing an
exchan
ge rate of
1.7 CHF
to th
e US
$. Whe
n used
with
rito
navir
as
booster
drug the do
se of s
aquin
avir
(soft
gel c
aps)
can
be red
uced
to2*
1000
mg or 1*1
600 mg
The ne
lfinavir
table
t pric
e inc
ludes a volu
me driv
en disc
ount
Nelfin
avir
table
t pric
e inc
ludes volu
me driv
en disc
ount
Elig
ible
org
aniz
atio
ns
Governme
nts,
interna
tiona
l organ
izatio
ns, N
GOs,
priva
tesecto
r organ
izatio
ns (e
.g., e
mploy
ers,
hospita
ls an
dins
urers
).Me
rck &
Co.,
Inc.
does not ru
le ou
t sup
plying
ARV
s to
patie
nts t
hrou
gh re
tail ph
arma
cies
Governme
nts,
NGOs
, priv
ate secto
r emp
loyers
Pric
e pe
r da
y in
US$
(FOB/
CIF/
DDU)
(DDD
)
1.64 (CI
F)(6*4
00 m
g)
2.82 (CI
F)(6*4
00 m
g)
1.37 (CI
F)(3*2
00 m
g)
2.52 (CI
F)(3*2
00 m
g)
2.35 (CI
F)(2*1
000 mg
to be comb
ined with
2*10
0 mg
RTV))
6.62 (CI
F)(3*1
200 mg
)6.4
7 (CI
F)(2*1
250 mg
)0.4
4 (CI
F)(3*0
.75 m
g)
Coun
trie
s ta
rget
ed
Low
HDI c
ountrie
s plus
med
ium H
DIcoun
tries w
ith adu
lt HIV prevale
nce of
1% or
grea
ter
Mediu
m HD
I cou
ntrie
s with
adu
lt HIV prevale
nce
less t
han 1%
Low
Huma
n De
velop
ment In
dex (HDI) c
ountrie
splu
s med
ium H
DI cou
ntrie
s with
adu
lt HIV
prevale
nce of
1% o
r greater
Mediu
m HD
I cou
ntrie
s with
adu
lt HIV prevale
nce
less t
han 1%
LDCs plus
sub-Saha
ran Afr
ica
Prod
ucts
indina
vir
efavir
enz
saqu
inavir
(hard gel c
aps)
saqu
inavir
(soft
gel
caps)
nelfin
avir
zalcitab
ine
Com
pany
Merck
Roche
Cont
’d
AAI:
Acceler
ating
Access
Initia
tive
FOB:
Free
on B
oard (
supp
lied
in ship
or a
ircraft), price
does
not
includ
e tra
nspo
rt or insuran
ce o
r cle
aran
ce c
harges t
o an
d in
the
coun
try o
f de
stina
tion
CIF:
Cost,
Insuran
ce, F
reigh
t. P
rice
includ
es t
ranspo
rt an
d ins
uran
ce t
o coun
try o
f bu
yer,
but
exclu
des
clearan
ce c
harges, i
mport
tax,
VAT
or s
ales
tax,
and
transpo
rt within
the
coun
try o
f the
buyer
DDU:
Delivered
to D
oor
of User: p
rice
includ
es a
ll costs
of
good
s, fre
ight,
insuran
ce, cle
aran
ce c
harges a
nd t
axes
HDI:
Hum
an D
evelo
pmen
t Ind
ex, in
scale
publi
shed
in
the
annu
al Hu
man
Develop
ment R
eport
by
the
Unite
d Na
tions D
evelo
pmen
t Prog
ram
(UND
P) t
o assess
the
develop
ment s
tatus
of coun
tries
LDCs
: Least
develop
ed c
ountrie
s, according
to
UNCTAD
NGO:
Nong
overnm
ental
orga
nization
Int. Accelerating Access... 7/01/03, 11:3430